Clinical trials: sponsored by Zimmer Biomet
Degenerative Disc Disease
Post-Market Surveillance Study of the TM Ardis Interbody Fusion System
This study is a post-market clinical follow-up study to fulfill the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2_Rev2_January 2012.
- Trial name
- NCT02429908
- Testing
- TM-Ardis Interbody
- Where
- 10 sites in Belgium, Canada and 4 more
- Volunteers
- 80 people
- Sponsor
- Zimmer Biomet
Arthropathy of Hip
Study Comparing BoneMaster Hydroxyapatite Coating With Plasma-sprayed Hydroxyapatite Coating on Acetabular Cups
The randomised controlled trial will be carried out on patients that require a total hip replacement (THR) to reduce pain and restore their function.
- Trial name
- NCT00859976
- Testing
- BoneMaster coated acetabular shell., Plasma Coated Acetabular Shell
- Where
- United Kingdom
- Volunteers
- 167 people
- Sponsor
- Zimmer Biomet
Herniated Disc, Radiculopathy
Slotted Hole Versus Fixed Hole C-Tek
The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.
- Conditions
- Herniated Disc, Radiculopathy, Spondylolysis
- Trial name
- NCT00585923
- Testing
- Fixed hole C-Tek™ Plate, Slotted hole C-Tek™ Plate
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Knee
Safety of NStride Autologous Protein Solution in the Treatment of Knee Osteoarthritis (PROGRESS I)
The primary objective of this study is to assess the safety of a single injection of APS.
- Trial name
- NCT02262364
- Testing
- APS
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Zimmer Biomet
Arthritis, Avascular Necrosis
A Prospective Clinical Study On A Total Hip Resurfacing System
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
- Trial name
- NCT00604734
- Testing
- ReCap Total Hip Resurfacing System
- Where
- Belgium
- Volunteers
- 280 people
- Sponsor
- Zimmer Biomet
Tibia Fracture Non Union Bone
Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions
The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a…
- Trial name
- NCT00726193
- Testing
- OsteoGen
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease
Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With TM-Ardis
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability. Assess whether the appropriate procedural modification facilitates clearer images when implanted with a…
- Trial name
- NCT02170558
- Testing
- TM- Ardis implant and Metal Reduction CT software
- Where
- United States
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease
Efficacy of the Aspen Spinous Process System in Anterior Lumbar Interbody Fusion (ALIF)
This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental posterior fixation using ASPEN Spinous Process…
- Trial name
- NCT01016314
- Testing
- Aspen Spinous Process System, Pedicle Screw Fixation
- Where
- 5 sites in United States
- Sponsor
- Zimmer Biomet
Bone Graft, Knee
OsseoFit™ Prospective Data Collection
This study compares the fill of bone graft sites in the knee. It is hypothesized that harvest sites, voids, and defects caused by trauma that are treated with the OsseoFit™ Porous Tissue Matrix™ device will achieve a better fill…
- Trial name
- NCT00708474
- Testing
- OsseoFit™ Porous Tissue Matrix™
- Where
- United States
- Sponsor
- Zimmer Biomet
Spondylolisthesis
Aspen Spinous Process Fixation System for Use in PLF in Patients With Spondylolisthesis
The purpose of this clinical investigation is to evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System.
- Trial name
- NCT01560273
- Testing
- Aspen Spinous Process Fixation Device
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Inflammatory Arthritis
Gender Solutions Natural Knee Post-Market Study
This is a prospective multicenter study of the Gender Solutions Natural Knee Flex System when used in primary total knee arthroplasty.
- Conditions
- Osteoarthritis, Inflammatory Arthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
- Trial name
- NCT01463566
- Testing
- Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System
- Sponsor
- Zimmer Biomet
Osteoarthritis, Rheumatoid Arthritis
Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Trial name
- NCT01010269
- Testing
- Vanguard Complete Knee, Vanguard High Flex RP
- Where
- 4 sites in South Korea
- Volunteers
- 300 people
- Sponsor
- Zimmer Biomet
Arthropathy of Hip
Short-Term Clinical Outcome of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing
The primary objectives of this clinical study include: Assess the rate of dislocation and fracture of THA using the new (the 4th generation) ceramic implants.
- Trial name
- NCT01103882
- Where
- 4 sites in South Korea
- Volunteers
- 277 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Rheumatoid Arthritis
A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System
The primary objectives of this pilot clinical study include: Evaluate clinical outcomes and quality of life on patients who received Vanguard PS Total Knee in Korean population Evaluate safety of Vanguard PS Total Knee in Korean…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Posttraumatic Deformity
- Trial name
- NCT01906177
- Where
- 2 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Total Knee Arthroplasty / Position of Customized X-Ray PSI Guides Using Optical Navigation
Zimmer CAS PSI X-Ray Knee in TKA (Total Knee Arthroplasty)
The objective of the observational study is to assess the positioning of customized guides designed from patients X-Rays (Zimmer® X-Ray PSI Knee) using optical navigation in primary total knee arthroplasty.
- Trial name
- NCT02504112
- Testing
- there is no intervention
- Volunteers
- 9 people
- Sponsor
- Zimmer Biomet
Degeneration of Lumbar Intervertebral Disc
Comparison of the Aspen Device Versus Pedicle Screws for Supplemental Posterior Fixation in Lumbar Interbody Fusion
The purpose of this clinical investigation is to evaluate the Aspen™ device compared to pedicle screw instrumentation for posterior fixation in the treatment of patients with degenerative disc disease and/or spondylolisthesis.
- Trial name
- NCT01549366
- Testing
- Aspen Spinous Process Fixation Device, Pedicle Screws
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Zimmer Biomet
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet
Gonarthrosis, Knee Osteoarthritis
Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)
This prospective single-center study will evaluate the safety and tolerability of a single dose of "APS(TM)" treated patients with OA of the knee who have failed conservative OA therapy.
- Conditions
- Gonarthrosis, Knee Osteoarthritis, Osteoarthritis
- Trial name
- NCT01773226
- Testing
- Autologous Protein Solution "APS(TM)"
- Where
- Netherlands
- Volunteers
- 11 people
- Sponsor
- Zimmer Biomet
Hip Athroplasty Using M2a Magnum
Metal-on-metal Hip Replacement MRI Study
This study is being conducted to determine the rate of symptomatic and asymptomatic nonmalignant, noninfective soft tissue mass presence (referred to in the literature as pseudotumour, ALVAL, ARMD, cysts or lesions) in primary…
- Trial name
- NCT03409640
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Sternal Fracture
Sternal Closure With SternaLock 360: First in Man Study
The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system.
- Trial name
- SL360 (NCT02686099)
- Testing
- SternaLock 360, Wire Cerclage
- Where
- South Africa
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet